FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANSATOME MICROKERATOME
K Number: K972808
·
Decision Oct 24, 1997
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
34
Review Days
88
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Basic Information
- Device Name
- HANSATOME MICROKERATOME
- K Number
- K972808
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Vision Corp.
- Date Received
- July 28, 1997
- Decision Date
- October 24, 1997
- Product Code
- HNO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Chiron Vision Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K970727 | MPORT FOLDABLE LENS PLACEMENT SYSTEM | Dec 17, 1997 | Substantially Equivalent |
| K960414 | SYNERGIST POWER PACK | Apr 24, 1996 | Substantially Equivalent |
| K944993 | IOLAB.SITE CD PHACOEMULSIFICATION MODULE | Oct 12, 1995 | Substantially Equivalent |
| K944995 | IOLAB/SITE PERISTALTIC MODULE | Oct 5, 1995 | Substantially Equivalent |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Jun 2, 1995 | Substantially Equivalent |
| K944994 | IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE | Mar 14, 1995 | Substantially Equivalent |
| K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT | Nov 22, 1994 | Substantially Equivalent |
| K935233 | IOLAB LACRIMAL DUCT CATHETER | Sep 15, 1994 | Substantially Equivalent |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | Aug 29, 1994 | Substantially Equivalent |
| K926412 | MICRON-SCOPE II | Jul 19, 1994 | Substantially Equivalent |